Alzheimer Disease Clinical Trial
Official title:
Enhancing Sleep Quality for Nursing Home Residents With Dementia: Pragmatic Trial of an Evidence-Based Frontline Huddling Program
This was a pilot study (R61) to prepare for a full clinical trial (R33) aiming to improve clinical outcomes for an important, growing, and vulnerable population-nursing home (NH) residents with Alzheimer's disease or related dementias (ADRDs). The goal was to pilot and refine the research methods and intervention that would be subsequently evaluated in a full implementation trial (hybrid type III). The goal of the evidence-based intervention (LOCK) that was refined in this pilot study and will be evaluated in the subsequent full clinical trial is to improve the sleep of NH residents with ADRD.
In community (non-VA) NHs [one from each of 3 national NH corporations], the multi-disciplinary research team achieved two aims: (1) refined the LOCK program to focus on sleep for residents with ADRD during this pilot (R61) phase, (2) which prepared the team for the second phase of this two-part NIA-funded grant (the R33 phase) to test the impact and sustainability of this intervention for NH residents with ADRD in an incomplete stepped-wedge randomized controlled trial. THIS PILOT STUDY R61 PHASE (1 YEAR; N = 3 NHS; 1 NH PER CORPORATION) HAD THE FOLLOWING SPECIFIC AIMS: 1. Refine the LOCK sleep program train-the-trainer protocol by implementing and pilot-testing in three NHs. 2. Test and refine the research methods to: effectively identify eligible NHs and residents; obtain consent; collect primary data from residents and staff (sleep time via actigraph); explore staff impressions of additional sleep measurement devices (Fitbits); transfer primary and secondary data to our data center; and merge all data. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04079803 -
PTI-125 for Mild-to-moderate Alzheimer's Disease Patients
|
Phase 2 | |
| Completed |
NCT04044495 -
Sleep, Rhythms and Risk of Alzheimer's Disease
|
N/A | |
| Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
| Recruiting |
NCT04520698 -
Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease
|
N/A | |
| Active, not recruiting |
NCT04606420 -
Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease
|
N/A | |
| Recruiting |
NCT05820919 -
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
|
N/A | |
| Terminated |
NCT03672474 -
REGEnLIFE RGn530 - Feasibility Pilot
|
N/A | |
| Completed |
NCT03430648 -
Is Tau Protein Linked to Mobility Function?
|
||
| Recruiting |
NCT04949750 -
Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
|
N/A | |
| Recruiting |
NCT04522739 -
Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease
|
Phase 4 | |
| Recruiting |
NCT05288842 -
Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
|
||
| Recruiting |
NCT05557409 -
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
|
Phase 3 | |
| Completed |
NCT06194552 -
A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07
|
Phase 1 | |
| Completed |
NCT03239561 -
Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants
|
Early Phase 1 | |
| Completed |
NCT03184467 -
Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients
|
Phase 2 | |
| Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
| Terminated |
NCT03487380 -
Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
|
N/A | |
| Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
| Recruiting |
NCT05328115 -
A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease
|
Phase 1 | |
| Completed |
NCT05562583 -
SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
|
N/A |